Numerous medical procedures require the advancement and positioning of elongate medical devices within body lumens. Intravascular catheters, in particular, are currently utilized in a wide variety of minimally invasive medical procedures. Such catheters often have an outer diameter in the range of two or less millimeters near their distal ends. The distal ends are often also highly flexible and may include softened distal tips. Further, some devices (coronary guide catheters, for example) include a formed distal end having a predefined curve adapted to interact in a desired manner with patient anatomy. Packaging these catheters for delivery and/or storage entails a number of concerns.
One packaging technique for catheters includes the use of a mounting card. Mounting cards are generally long, somewhat narrow (100+cm by 10-20 cm) cards having a plurality of die-cut tabs that hold the catheter in place. These die-cut tabs are usually created using a manual press that cuts the specific shape of the tab into the mounting card. Once the tabs are cut, the tabs are then raised, allowing the catheter to be woven under the tabs. The tabs are then released and deflect back toward the mounting card, such that the catheter to be held in place by the tabs' downward pressure. One in the art generally knows this weaving procedure as “webbing.”
Once mounted on the card, the catheter and mounting card are then wrapped in a sterile barrier, sometimes known as an envelope, and then sealed. The sterile barrier may also be secured down to the card at chosen locations.
Physicians have found that catheters fastened by tabs sometimes succumb to physical deformation during the catheter's removal. With the sterile barrier placed over and around the catheter and mounting card, the catheter is typically removed by simple pulling the catheter through the tabs. Because the distal end is generally the most flexible region of the catheter, the distal end may be deformed and/or kinked quite readily. Pulling the device through a tab may easily impart a new structural formation to the catheter that was not desired by the manufacturer. A further difficulty can arise because the sterile barrier touches the catheter itself, creating additional friction during catheter removal. Extra force is then required to remove the catheter, again subjecting portions of the catheter shaft to stresses that may lead to deformation and/or kinking.
Also, because the sterile barrier is often provided such that it holds the catheter against the catheter holding card, the canting (out of plane curvature) provided in certain catheter types can become distorted or damaged either during removal, or during storage and shipping. For example, certain guiding catheters for accessing the aortic arch include curvatures at their distal ends which do not lie in a single plane. Thus, when placed on a generally flat catheter holding card and pressed down on the card, these catheters may lose their desired shape and become less suitable for their intended purpose. Each of these are examples of damage that can result with known catheter packaging systems. There is an ongoing need to provide alternative designs and methods of making and using packaging for medical devices.